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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNUVASIVE PCM CERVICAL DISC SYSTEM
Classification Nameprosthesis, intervertebral disc
ApplicantNUVASIVE, INC.
PMA NumberP100012
Date Received04/01/2010
Decision Date10/26/2012
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 12M-1111
Notice Date 11/08/2012
Advisory Committee Orthopedic
Clinical Trials NCT00578812
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the pcm cervical disc system. This device is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from c3-c4 to c6-c7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and manifested by at least one of the following conditions confirmed by radiographic imaging (ct, mri, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The pcm cervical disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the pcm cervical disc.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 
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